Received Nov 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | MA2506 | — |
one quarter of an inch white contaminant inside the vaccine; This is a spontaneous report received from an Other HCP from product quality group. A patient (age and gender not provided) received pneumococcal 20-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: MA2506, Expiration Date: 31Oct2026) for immunisation, Device Lot Number: MA2506, Device Expiration Date: 31Oct2026. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIQUID PRODUCT PHYSICAL ISSUE (non-serious), outcome "unknown", described as "one quarter of an inch white contaminant inside the vaccine". Additional information: the pharmacist reported a contaminant in one of the vaccines that she was about to administer. When the pharmacist peeled off the sticker, she could see "that big, it's about one quarter of an inch white contaminant inside the vaccine." The pharmacist confirmed the vaccine was not administered to any patient. The pharmacist stated, "No, not yet because I was peeling off the sticker to put on my consent form and that's when I see it." The pharmacist further described that the "contaminant" was floating or stuck in the vial. The pharmacist also stated the floating object was about a quarter of an inch, white and opaque. Causality for "one quarter of an inch white contaminant inside the vaccine" was determined associated to device constituent of pneumococcal 20-valent conjugate vaccine (diphtheria crm197 protein) (malfunction).